Prospective Grant of an Exclusive Patent License: Methods and Compositions for Adoptive Cell Therapy, 18577-18578 [2020-06922]
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18577
Federal Register / Vol. 85, No. 64 / Thursday, April 2, 2020 / Notices
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
State Plan (OCSE–100) ..................................................................................
State Plan Transmittal (OCSE–21–U4) ...........................................................
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54
54
Estimated Total Annual Burden
Hours: 486.
and Research Training, National Institutes of
Health, HHS)
(Authority: Sections 452, 454, and 466 of the
Social Security Act)
Mary B. Jones,
ACF/OPRE Certifying Officer.
Dated: March 27, 2020.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–06869 Filed 4–1–20; 8:45 am]
[FR Doc. 2020–06870 Filed 4–1–20; 8:45 am]
BILLING CODE 4184–41–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Prospective Grant of an Exclusive
Patent License: Methods and
Compositions for Adoptive Cell
Therapy
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel CTSA.
Date: May 8, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Virtual and
Teleconference Meeting).
Contact Person: Victor Henriquez, Ph.D.,
Scientific Review Officer, Office of Scientific
Director, National Center for Advancing
Translational Sciences (NCATS), National
Institutes of Health, 6701 Democracy Blvd.,
Democracy 1, Room 1080, Bethesda, MD
20892–4878, 301–435–0813 henriquv@
mail.nih.gov,
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
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AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
Patents and Patent Applications listed
in the Supplementary Information
section of this Notice to Lyell
Immunopharma, Inc. (‘‘Lyell’’), located
in South San Francisco, CA.
SUMMARY:
Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before April 17, 2020 will be
considered.
DATES:
Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Andrew Burke, Ph.D.,
Senior Technology Transfer Manager,
NCI Technology Transfer Center, 9609
Medical Center Drive, RM 1E530, MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702; Telephone: (240) 276–5484;
Facsimile: (240) 276–5504; Email:
andy.burke@nih.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
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Total
number of
responses per
respondent
Average
burden hours
per response
12
12
Total
burden hours
.5
.25
324
162
Intellectual Property
Group A
E–022–2017: Methods for Selecting
Therapy for a Cancer Patient
1. US Provisional Patent Application
62/418,461 filed November 7, 2016 (E–
022–2017–0–US–01);
2. International Patent Application
PCT/US2017/060304 filed November 7,
2017 (E–022–2017–0–PCT–02);
3. European Patent Application
17805342.7 filed May 6, 2019 (E–022–
2017–0–EP–03); and
4. United States Patent Application
16/347,778 filed May 6, 2019 (E–022–
2017–0–US–04).
Group B
E–250–2016: Methods of Preparing an
Isolated or Purified Population of
Thymic Emigrant Cells and Methods of
Treatment Using the Same
1. US Provisional Patent Application
62/433,591 filed December 13, 2016 (E–
250–2016–0–US–01);
2. International Patent Application
PCT/US2017/065986 filed December 13,
2017 (E–250–2016–0–PCT–02);
3. European Patent Application
17825696.2 filed June 11, 2019 (E–250–
2016–0–EP–03); and
4. United States Patent Application
16/468,890 filed June 12, 2019 (E–250–
2016–0–US–04).
E–132–2017: Methods of Preparing
Hematopoietic Progenitor Cells In Vitro
1. US Provisional Patent Application
62/583,240 filed November 8, 2017 (E–
132–2017–0–US–01); and
2. International Patent Application
PCT/US2018/059856 filed November 8,
2018 (E–132–2017–0–PCT–02).
E–133–2017: In Vitro Generation of
Thymic Organoid From Human
Pluripotent Stem Cells
1. US Provisional Patent Application
62/560,908 filed September 20, 2017 (E–
133–2017–0–US–01); and
2. International Patent Application
PCT/US2018/051625 filed September
19, 2018 (E–133–2017–0–PCT–02).
E:\FR\FM\02APN1.SGM
02APN1
18578
Federal Register / Vol. 85, No. 64 / Thursday, April 2, 2020 / Notices
E–091–2019: Methods of Producing T
Cell Populations Using Induced
Pluripotent Stem Cells
1. US Provisional Patent Application
62/957,939 filed January 7, 2020 (E–
091–2019–0–US–01).
Group C
E–174–2012: Methods of Producing T
Memory Stem Cell Populations
1. International Patent Application
PCT/US2012/053947 filed September 6,
2012 (E–174–2012–0–PCT–01);
2. United States Patent 10,316,289
issued June 11, 2019 (E–174–2012–0–
US–02.; and
3. United States Patent Application
16/410,327 filed May 13, 2019 (E–174–
2012–0–US–03).
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
fields of use may be limited to the
following:
Field of Use Applying to Intellectual
Property Group A
‘‘Manufacture and commercialization
of companion diagnostics approved or
cleared by the FDA or equivalent foreign
regulatory agency for Licenseeproprietary T cell therapy products.’’
Field of Use Applying to Intellectual
Property Group B
‘‘Manufacture and commercialization
of adoptive T cell therapy products
generated from autologously-derived,
induced pluripotent stem cells for the
treatment of cancer in humans.’’
jbell on DSKJLSW7X2PROD with NOTICES
Field of Use Applying to Intellectual
Property Group C
‘‘Manufacture and commercialization
of adoptive T cell therapy products
isolated from peripheral blood for the
treatment of cancer in humans.’’
E–022–2017 generally discloses
methods of using certain gene signature
profiles to identify cancer patients likely
to respond to T cell immunotherapy.
E–250–2016 generally discloses in
vitro methodologies for generating
induced pluripotent stem cell-based
thymic emigrants and methods of using
the same for the treatment of cancer.
E–132–2017 generally discloses
methods of generating multi-potent
hematopoietic progenitor cells from
induced pluripotent stem cells and
methods of using the same for the
treatment of cancer.
E–133–2017 generally discloses
methods of generating autologous
thymic organoids from human
VerDate Sep<11>2014
18:34 Apr 01, 2020
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pluripotent stem cells and methods of
treating cancer using T cells produced
by such organoids.
E–091–2019 generally discloses
methods of reprogramming tumor
infiltrating lymphocytes into induced
pluripotent stem cells and methods of
treating cancer using such cells.
E–174–2012 generally discloses a
method of generating stem cell-like
memory T cells by stimulating naive T
cells in the presence of GSK–3beta
inhibitors, and methods of treating
cancer using cells conditioned in such
a manner.
This Notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published Notice, the National
Cancer Institute receives written
evidence and argument which
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.
License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information from these license
applications will be made only as
required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: March 23, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2020–06922 Filed 4–1–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
joint meeting of the National Cancer
Advisory Board and NCI Board of
Scientific Advisors.
The meeting will be held as a virtual
meeting and is open to the public.
Individuals who plan to view the virtual
PO 00000
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meeting and need special assistance or
other reasonable accommodations to
view the meeting, should notify the
Contact Person listed below in advance
of the meeting.
A portion of the National Cancer
Advisory Board meeting will be closed
to the public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended,
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Advisory Board and NCI Board of Scientific
Advisors.
Date: April 9, 2020.
Open: 1:00 p.m. to 3:15 p.m.
Agenda: Joint meeting of the National
Cancer Advisory Board and NCI Board of
Scientific Advisors, NCI Director’s report and
other related business.
Closed: 3:15 p.m. to 4:00 p.m.
Agenda: Review of ongoing intramural
research efforts and the discussion of
confidential personnel issues.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Rockville,
MD 20850 (Virtual Meeting).
Instructions regarding access to the
meeting can be found here:
NCAB: https://deainfo.nci.nih.gov/advisory/
ncab/ncabmeetings.htm
BSA: https://deainfo.nci.nih.gov/advisory/
bsa/bsameetings.htm
Contact Person: Paulette S. Gray, Ph.D.,
Executive Secretary, Division of Extramural
Activities, National Cancer Institute—Shady
Grove, National Institutes of Health, 9609
Medical Center Drive, 7th Floor, Room
7W444, Bethesda, MD 20892, 240–276–6340,
grayp@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page:
NCAB: https://deainfo.nci.nih.gov/advisory/
ncab/ncabmeetings.htm,
BSA: https://deainfo.nci.nih.gov/advisory/
bsa/bsameetings.htm, where an agenda,
instructions for access, and any additional
information for the meeting will be posted
when available.
This notice is being published less than 15
days prior to the meeting due to scheduling
difficulties.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
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[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Notices]
[Pages 18577-18578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License: Methods and
Compositions for Adoptive Cell Therapy
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Cancer Institute, an institute of the National
Institutes of Health, Department of Health and Human Services, is
contemplating the grant of an Exclusive Patent License to practice the
inventions embodied in the Patents and Patent Applications listed in
the Supplementary Information section of this Notice to Lyell
Immunopharma, Inc. (``Lyell''), located in South San Francisco, CA.
DATES: Only written comments and/or applications for a license which
are received by the National Cancer Institute's Technology Transfer
Center on or before April 17, 2020 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated Exclusive Patent License
should be directed to: Andrew Burke, Ph.D., Senior Technology Transfer
Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM
1E530, MSC 9702, Bethesda, MD 20892-9702 (for business mail),
Rockville, MD 20850-9702; Telephone: (240) 276-5484; Facsimile: (240)
276-5504; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Intellectual Property
Group A
E-022-2017: Methods for Selecting Therapy for a Cancer Patient
1. US Provisional Patent Application 62/418,461 filed November 7,
2016 (E-022-2017-0-US-01);
2. International Patent Application PCT/US2017/060304 filed
November 7, 2017 (E-022-2017-0-PCT-02);
3. European Patent Application 17805342.7 filed May 6, 2019 (E-022-
2017-0-EP-03); and
4. United States Patent Application 16/347,778 filed May 6, 2019
(E-022-2017-0-US-04).
Group B
E-250-2016: Methods of Preparing an Isolated or Purified Population of
Thymic Emigrant Cells and Methods of Treatment Using the Same
1. US Provisional Patent Application 62/433,591 filed December 13,
2016 (E-250-2016-0-US-01);
2. International Patent Application PCT/US2017/065986 filed
December 13, 2017 (E-250-2016-0-PCT-02);
3. European Patent Application 17825696.2 filed June 11, 2019 (E-
250-2016-0-EP-03); and
4. United States Patent Application 16/468,890 filed June 12, 2019
(E-250-2016-0-US-04).
E-132-2017: Methods of Preparing Hematopoietic Progenitor Cells In
Vitro
1. US Provisional Patent Application 62/583,240 filed November 8,
2017 (E-132-2017-0-US-01); and
2. International Patent Application PCT/US2018/059856 filed
November 8, 2018 (E-132-2017-0-PCT-02).
E-133-2017: In Vitro Generation of Thymic Organoid From Human
Pluripotent Stem Cells
1. US Provisional Patent Application 62/560,908 filed September 20,
2017 (E-133-2017-0-US-01); and
2. International Patent Application PCT/US2018/051625 filed
September 19, 2018 (E-133-2017-0-PCT-02).
[[Page 18578]]
E-091-2019: Methods of Producing T Cell Populations Using Induced
Pluripotent Stem Cells
1. US Provisional Patent Application 62/957,939 filed January 7,
2020 (E-091-2019-0-US-01).
Group C
E-174-2012: Methods of Producing T Memory Stem Cell Populations
1. International Patent Application PCT/US2012/053947 filed
September 6, 2012 (E-174-2012-0-PCT-01);
2. United States Patent 10,316,289 issued June 11, 2019 (E-174-
2012-0-US-02.; and
3. United States Patent Application 16/410,327 filed May 13, 2019
(E-174-2012-0-US-03).
The patent rights in these inventions have been assigned and/or
exclusively licensed to the government of the United States of America.
The prospective exclusive license territory may be worldwide, and
the fields of use may be limited to the following:
Field of Use Applying to Intellectual Property Group A
``Manufacture and commercialization of companion diagnostics
approved or cleared by the FDA or equivalent foreign regulatory agency
for Licensee-proprietary T cell therapy products.''
Field of Use Applying to Intellectual Property Group B
``Manufacture and commercialization of adoptive T cell therapy
products generated from autologously-derived, induced pluripotent stem
cells for the treatment of cancer in humans.''
Field of Use Applying to Intellectual Property Group C
``Manufacture and commercialization of adoptive T cell therapy
products isolated from peripheral blood for the treatment of cancer in
humans.''
E-022-2017 generally discloses methods of using certain gene
signature profiles to identify cancer patients likely to respond to T
cell immunotherapy.
E-250-2016 generally discloses in vitro methodologies for
generating induced pluripotent stem cell-based thymic emigrants and
methods of using the same for the treatment of cancer.
E-132-2017 generally discloses methods of generating multi-potent
hematopoietic progenitor cells from induced pluripotent stem cells and
methods of using the same for the treatment of cancer.
E-133-2017 generally discloses methods of generating autologous
thymic organoids from human pluripotent stem cells and methods of
treating cancer using T cells produced by such organoids.
E-091-2019 generally discloses methods of reprogramming tumor
infiltrating lymphocytes into induced pluripotent stem cells and
methods of treating cancer using such cells.
E-174-2012 generally discloses a method of generating stem cell-
like memory T cells by stimulating naive T cells in the presence of
GSK-3beta inhibitors, and methods of treating cancer using cells
conditioned in such a manner.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive license will be royalty bearing,
and the prospective exclusive license may be granted unless within
fifteen (15) days from the date of this published Notice, the National
Cancer Institute receives written evidence and argument which
establishes that the grant of the license would not be consistent with
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public may file comments or
objections. Comments and objections, other than those in the form of a
license application, will not be treated confidentially, and may be
made publicly available.
License applications submitted in response to this Notice will be
presumed to contain business confidential information and any release
of information from these license applications will be made only as
required and upon a request under the Freedom of Information Act, 5
U.S.C. 552.
Dated: March 23, 2020.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2020-06922 Filed 4-1-20; 8:45 am]
BILLING CODE 4140-01-P
